Parion, Santen Pharma to develop P-321 for dry eye disease

On May 1, 2014 Parion announced FDA Acceptance of the Investigational New Drug Application for clinical testing of P-321 Ophthalmic Solution for the Treatment of Dry Eye Disease. Parion plans to initiate a Phase 1/2a clinical trial in patients suffering from dry eye disease in July, 2014 in the United States.

Under the terms of agreement, Santen will make an undisclosed option payment to secure certain rights to P-321 and to support the upcoming Phase 1/2a clinical trial.

Should Santen elect to exercise their option, Santen will have responsibility for all clinical, regulatory, and commercial activity for the ophthalmic use of P-321 in the agreed Asian territories. Parion retains all rights to develop and commercialize P-321 in the rest of the world, including North America and Europe.

"Parion is excited to be partnering with Santen, a global leader in Ophthalmology, who has a proven track record in commercializing multiple dry eye products in Asia," said Paul Boucher, President of Parion Sciences.

"P-321’s unique mechanism of action aims to restore the eye’s tear film volume, which is expected to bring relief for those patients with dry eye. The combined expertise of the Parion and Santen teams will greatly benefit the P-321 program and our collaborative Phase 1/2a study."

The epithelial sodium channel (ENaC) plays a key role in the regulation of tear film volume and is, therefore, an attractive target for the treatment of dry eye. Studies with preclinical models of dry eye disease have demonstrated that by blocking ENaC, the tear film volume is restored, maintaining its protective and lubricating actions on the ocular surface.

P-321 is the product of a comprehensive research effort to develop a potent ENaC inhibitor with unique pharmacokinetic and pharmacodynamic characteristics designed for topical ocular administration, metabolic stability and limited systemic exposure.

Parion Sciences has completed all the preclinical safety and mechanistic studies required to initiate clinical studies in humans in the US. Parion’s dry eye program was supported by the NIH through the National Eye Institute and the National Center for Advancing Translational Sciences (NCATS) BrIDGs program.